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Details for New Drug Application (NDA): 075502

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NDA 075502 describes CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE, which is a drug marketed by Actavis Mid Atlantic, Fougera Pharms, Taro, and Glenmark Pharms, and is included in six NDAs. It is available from fourteen suppliers. Additional details are available on the CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE profile page.

The generic ingredient in CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE is betamethasone dipropionate; clotrimazole. There are sixty-six drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the betamethasone dipropionate; clotrimazole profile page.

Summary for NDA: 075502

Tradename:
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE
Applicant:
Fougera Pharms
Ingredient:
betamethasone dipropionate; clotrimazole
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 075502

Ingredient-typeAzoles
Mechanism of ActionCorticosteroid Hormone Receptor Agonists

Suppliers and Packaging for NDA: 075502

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE
betamethasone dipropionate; clotrimazole
CREAM;TOPICAL 075502 ANDA E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. 0168-0258 0168-0258-15 15 g in 1 TUBE (0168-0258-15)
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE
betamethasone dipropionate; clotrimazole
CREAM;TOPICAL 075502 ANDA E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. 0168-0258 0168-0258-46 45 g in 1 TUBE (0168-0258-46)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrengthEQ 0.05% BASE;1%
Approval Date:Jun 5, 2001TE:ABRLD:No


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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